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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): March 01, 2022

 

 

CEREVEL THERAPEUTICS HOLDINGS, INC.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware			001-39311	85-3911080
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
222 Jacobs Street Suite 200
Cambridge, Massachusetts				02141
(Address of Principal Executive Offices)				(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: 844 304-2048

 

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common stock, par value $0.0001 per share		CERE		The NASDAQ Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

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Item 2.02 Results of Operations and Financial Condition.

On March 1, 2022, Cerevel Therapeutics Holdings, Inc. issued a press release announcing financial results for the quarter and year ended December 31, 2021. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.

 

The information contained in this Current Report on Form 8-K and Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit No.		Description
99.1		Press release issued by Cerevel Therapeutics Holdings, Inc. on March 1, 2022, furnished herewith.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

			CEREVEL THERAPEUTICS HOLDINGS, INC.
Date:	March 1, 2022	By:	/s/ Mark Bodenrader
			Mark Bodenrader Interim Chief Financial Officer

 

 

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Exhibit 99.1

 

 

Cerevel Therapeutics Provides Update on Pipeline Progress along with Fourth Quarter and Full Year 2021 Financial Results

Announced positive results from Phase 1 healthy volunteer trial of darigabat in acute anxiety

On track to initiate two parallel adequately-powered Phase 2 trials of emraclidine in schizophrenia by mid-year 2022

Multiple late-stage clinical readouts expected in the next 18 months

Conference call today at 8:00 AM EST

 

CAMBRIDGE, Mass., Mar. 1, 2022 -- Cerevel Therapeutics, (Nasdaq: CERE), a company dedicated to unraveling the mysteries of the brain to treat neuroscience diseases, today reported financial results for the fourth quarter and full year ended December 31, 2021 and provided key business updates.

“Cerevel continues to demonstrate that our targeted approach to neuroscience – which is grounded in a deep understanding of neurocircuitry, receptor subtype selectivity and differentiated pharmacology – can deliver hope for patients struggling with neuroscience diseases,” said Tony Coles, M.D., chairman and chief executive officer of Cerevel Therapeutics. “By bringing together the people, the pipeline, and the capital we need – and taking a deliberate and thoughtful method to clinical trial design and execution – Cerevel is changing what is possible in neuroscience.”

Pipeline Highlights

Leveraging its deep understanding of neurocircuitry and receptor subtype selectivity, Cerevel continues to execute on its broad, diverse pipeline of novel neuroscience drug candidates. Below are the latest updates for Cerevel’s lead programs.

Emraclidine (formerly CVL-231): Emraclidine is an M4-selective positive allosteric modulator (PAM) in development as a once-daily medication for schizophrenia without the need for titration.

 

 

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Darigabat: Darigabat is an α2/3/5-selective GABAA receptor PAM currently under development for anxiety and epilepsy.

Tavapadon: Tavapadon is a D1/D5 partial agonist currently in Phase 3 trials for the treatment of Parkinson’s disease.

 

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CVL-871: CVL-871 is a D1/D5 partial agonist in development for treatment of dementia-related apathy.

In addition to these lead programs, Cerevel is advancing its early clinical pipeline and discovery programs which include:

Financial Results for the Fourth Quarter and Full Year 2021

 

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Financial Outlook

Conference Call Information

Cerevel will host a conference call and webcast today, March 1, at 8:00 a.m. EST to discuss its fourth quarter and full year 2021 financial results and pipeline updates. To access the call, please dial 833-665-0655 (domestic) or 702-495-1044 (international) and refer to conference ID 6298779. The live webcast and accompanying slides can be accessed on the investor relations section of the Cerevel Therapeutics website here. A replay will be available in the same section of the company’s website for approximately 90 days.

About Cerevel Therapeutics
Cerevel Therapeutics is dedicated to unraveling the mysteries of the brain to treat neuroscience diseases. The company is tackling diseases with a targeted approach to neuroscience that combines expertise in neurocircuitry with a focus on receptor selectivity. Cerevel Therapeutics has a diversified pipeline comprising six clinical-stage investigational therapies and several pre-clinical compounds with the potential to treat a range of neuroscience diseases, including Parkinson’s, epilepsy, schizophrenia, and dementia-related apathy. Headquartered in Cambridge, Mass., Cerevel Therapeutics is advancing its current research and development programs while exploring new modalities through internal research efforts, external collaborations, or potential acquisitions. For more information, visit www.cerevel.com.

Special Note Regarding Forward-Looking Statements

This press release contains forward-looking statements that are based on management’s beliefs and assumptions and on information currently available to management. In some cases, you

 

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can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, statements about the potential attributes and benefits of our product candidates, the format and timing of our product development activities and clinical trials, including the timing, details and objectives of the emraclidine Phase 2 program and related nonclinical and clinical safety pharmacology studies, evaluation of this mechanism in other populations, including dementia-related psychosis, the timing of other key upcoming milestones and other statements regarding the design of clinical trials and preclinical studies and the timing of initiation, completion and data readouts for clinical trials, the timing and outcome of regulatory interactions, expectations for R&D and G&A expenses in 2022 and the sufficiency of our cash, cash equivalents and marketable securities. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. Actual performance and results may differ materially from those projected or suggested in the forward-looking statements due to various risks and uncertainties, including, among others: clinical trial results may not be favorable; uncertainties inherent in the product development process (including with respect to the timing of results and whether such results will be predictive of future results); the impact of COVID-19 on the timing, progress and results of ongoing or planned clinical trials; other impacts of COVID-19, including operational disruptions or delays or to our ability to raise additional capital; whether and when, if at all, our product candidates will receive approval from the FDA or other regulatory authorities, and for which, if any, indications; competition from other biotechnology companies; uncertainties regarding intellectual property protection; and other risks identified in our SEC filings, including those under the heading “Risk Factors” in our Quarterly Report on Form 10-Q filed with the SEC on November 10, 2021 and our subsequent SEC filings. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. The forward-looking statements in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.

 

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Media Contact:

Anna Robinson

Cerevel Therapeutics

anna.robinson@cerevel.com

 

Investor Contact:

Matthew Calistri

Cerevel Therapeutics

matthew.calistri@cerevel.com

 

 

 

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TABLE 1
CEREVEL THERAPEUTICS HOLDINGS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited, in thousands, except share amounts and per share amounts)
		For the Three Months Ended December 31,								For the Twelve Months Ended December 31,
		2021				2020				2021				2020
Operating expenses:
Research and development		$	47,841			$	30,135			$	161,855			$	103,303
General and administrative			16,649				11,761				58,243				45,813
Total operating expenses			64,490				41,896				220,098				149,116
Loss from operations			(64,490	)			(41,896	)			(220,098	)			(149,116	)
Interest income, net			119				14				157				224
Other income (expense), net			5,316				8,702				(5,393	)			(3,274	)
Loss before income taxes			(59,055	)			(33,180	)			(225,334	)			(152,166	)
Income tax benefit (provision), net			—				3				—				24
Net loss		$	(59,055	)		$	(33,177	)		$	(225,334	)		$	(152,142	)
Reconciliation of net loss attributable to common stockholders:
Net loss		$	(59,055	)		$	(33,177	)		$	(225,334	)		$	(152,142	)
Benefit related to the redemption of Series A-1 redeemable convertible preferred stock at less than the carrying value			—				3,871				—				3,871
Net loss attributable to common stockholders		$	(59,055	)		$	(29,306	)		$	(225,334	)		$	(148,271	)
Net loss per share attributable to common stockholders, basic and diluted		$	(0.40	)		$	(0.27	)		$	(1.65	)		$	(2.01	)
Weighted-average shares used in calculating net loss per share, basic and diluted			147,302,283				109,135,851				136,576,536				73,643,315

 

 

 

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TABLE 2
CEREVEL THERAPEUTICS HOLDINGS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited, in thousands)
		As of December 31,
		2021				2020
ASSETS
Current assets:
Cash and cash equivalents		$	193,018			$	383,623
Marketable securities			372,670				—
Prepaid expenses and other current assets			12,329				6,937
Total current assets			578,017				390,560
Marketable securities			52,269				—
Property and equipment, net			28,449				24,165
Operating lease assets			23,251				24,459
Restricted cash			4,200				4,200
Other long-term assets			2,733				1,889
Total assets		$	688,919			$	445,273
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable		$	11,298			$	4,993
Accrued expenses and other current liabilities			28,803				22,519
Operating lease liabilities, current portion			2,437				2,036
Total current liabilities			42,538				29,548
Operating lease liabilities, net of current portion			34,110				30,969
Other long-term liabilities			33,542				236
Total stockholders’ equity			578,729				384,520
Total liabilities and stockholders’ equity		$	688,919			$	445,273

 

 

 

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TABLE 3
CEREVEL THERAPEUTICS HOLDINGS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited, in thousands)
		For the year ended December 31,
		2021				2020
Net cash flows used in operating activities		$	(178,546	)		$	(117,802	)
Net cash flows used in investing activities			(435,661	)			(18,892	)
Net cash flows provided by financing activities			423,602				440,835
Net increase (decrease) in cash, cash equivalents, and restricted cash			(190,605	)			304,141
Cash, cash equivalents and restricted cash, beginning of the period			387,823				83,682
Cash, cash equivalents and restricted cash, end of the period		$	197,218			$	387,823

 

Note:
Cash, cash equivalents and restricted cash balances include restricted cash of $4.2 million as of December 31, 2021 and December 31, 2020.

 

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